Spatial analysis and validation of glioblastoma on 7 T MRI

Completed

Conditions: astrocytoma grade IV
Glioblastoma
malignant braintumour
10029211

Registration Number: NL-OMON44436

Lead Sponsor: MAASTRO Clinic

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

Healthy volunteers
Subjects with no priorly defined clinical conditions, Age 18 years and older (no maximum age), Ability to comply to study procedure, Informed consent by signing informed consent form regarding this study;Patients
Supratentorial tumour, suspected GBM on diagnostic 3T MRI, eligible for biopsy, Minimum age 18 years or older, WHO Performance scale *2, ASA class * 3, understanding of the Dutch language, ability to comply to study procedure

Exclusion Criteria

Healthy volunteers
Contra-indications for 7T MRI;Patients
Recurrent tumour, tumour location deemed unfit for extra biopsies, prior radiotherapy to the skull, prior chemotherapy, eligibility for immediate debulking, contra-indications for the MRI.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study endpoint<br /><br>* The co-localisation of the GTV on the 7T MRI and 3T MRI</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoints<br /><br>* The correspondence between glioblastoma cells found in the biopsies and<br /><br>region of interest (ROI) on the 7T MRI scan.<br /><br>* The co-localisation of the CTV on the 7T MRI and 3T MRI<br /><br>* The co-localisation of the organs at risk (OAR) on the 7T - and 3T MRI<br /><br>* The correlation between the first tumour recurrence on 3T MRI follow-up<br /><br>images and ROI on the 7T MRI scan<br /><br>* The quantification of tumour heterogeneity on 7T MRI and 3T MRI<br /><br>* The visibility of white matter tracts on 7T MRI and 3T MRI<br /><br>* Tolerability and side effects 3T MRI and 7T MRI scan with a specific MRI<br /><br>questionnaire after both scans.</p><br>